Name
Harri Jarvelainen
Educational Degrees
DVM, PhD
Certifications
DABT - Diplomate American Board of Toxicology, ERT - European Registered Toxicologist
Education
- Doctor of Veterinary Medicine - DVM (University of Helsinki)
- PhD in Toxicology (University of Helsinki)
- DABT (Diploma of American Board of Toxicology)
- ERT (Eurotox Registered Toxicologist)
- Adjunct Professor of Toxicology
Expertise
Biologics/Biotherapeutics/Biotechnology, Carcinogenicity, Cardiovascular Toxicology, Clinical Trials (Phases I- II- III- IV), Consumer Products, Dermal Toxicology, Developmental and Reproductive Toxicology, Dietary Supplements, Drug/Pharmaceutical Development, Food and Food Additives, Genetic Toxicology and Cytogenetics, GLP Study Auditing, Hematologic Toxicology, Hepatic Toxicology, Immunotoxicology, In Vitro Toxicology, Industrial and Occupational Toxicology, Inhalation and Respiratory Toxicology, MSDS And Labels (Hazard Communication), Neurotoxicology, Ocular Toxicology, Pharmacokinetics/Toxicokinetics, Product Safety Assessment, Regulatory Toxicology, Renal Toxicology, Risk Assessment, Safety Pharmacology, Toxicologic Pathology, Training and Training Courses, Veterinary Products, Veterinary Toxicology
Specialties
Drug discovery and development, IND, NDA, discovery toxicology, peptides, small molecules, antibodies, pharmaceuticals, biologicals, pharmacology, liver toxicology, hepatotoxicology, project management, veterinary, animal welfare, China CRO, Australia
Experience
www.biotechgo.com
I am a Doctor of Veterinary Medicine, PhD and Adj Professor of Toxicology with 20 years of experience in Pharmaceutical Discovery & Development (e.g. AstraZeneca in Sweden and Canada), Toxicology & Pharmacology and IND/CTA package planning & preparation. Board Certification in Toxicology both from the US (DABT; 2006-) and Europe (ERT; 2004-). Experience in managing more than 30 drug development projects and programs - small molecule and various types of biologicals (e.g. peptides, ADCs) - from target discovery to early development, for a variety of indications (oncology, inflammation, infective, hormonal etc).

In my current Independent Preclinical Consultant role, my focus is on managing discovery / preclinical / toxicology programs (mostly IND-enabling) and preparation of regulatory submissions to Western agencies (US FDA, EMA, Australia TGA) and/or the Chinese FDA (CFDA). Clients include small-medium size pharma from the US, Europe, Australia and Asia.

I have been based in China and Australia part time since 2012 and always prefer to utilize the top FDA-inspected preclinical CROs and manufacturing CMOs in China and clinical CROs in Australia for most of my clients.
City
Solana Beach
State
CA
Zip Code
92075
Country
USA